Implanted Electrical Stimulator for Spinal Cord
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UnitedHealthcare of California (HMO)
UnitedHealthcare Benefits Plan of California (EPO/POS)
UnitedHealthcare of Oklahoma, Inc.
UnitedHealthcare of Oregon, Inc.
UnitedHealthcare Benefits of Texas, Inc.
UnitedHealthcare of Washington, Inc.
UnitedHealthcare® West
Medical Management Guideline
Implanted Electrical Stimulator for Spinal Cord
Guideline Number: MMG064.S
Effective Date: April 1, 2023 Instructions for Use
Table of Contents Page Related Medical Management Guidelines
Coverage Rationale ....................................................................... 1 • Bariatric Surgery
Documentation Requirements ...................................................... 2 • Electrical Stimulation for the Treatment of Pain and
Applicable Codes .......................................................................... 2 Muscle Rehabilitation
Clinical Evidence ........................................................................... 3
• Gastrointestinal Motility Disorders, Diagnosis and
U.S. Food and Drug Administration ........................................... 11
Treatment
References ................................................................................... 11
• Occipital Nerve Injections and Ablation (Including
Guideline History/Revision Information ..................................... 13
Occipital Neuralgia and Headache)
Instructions for Use ..................................................................... 13
Coverage Rationale
Implanted electrical spinal cord stimulators are proven and medically necessary for treating the following conditions in
certain circumstances, when performed according to U.S. Food and Drug Administration (FDA) labeled indications,
contraindications, warnings and precautions:
Complex regional pain syndrome (CRPS)
Painful lower limb diabetic neuropathy
Failed back surgery syndrome
Implanted electrical spinal cord stimulators are unproven and not medically necessary for treating the following
conditions due to insufficient evidence of efficacy:
• Chronic intractable back pain without prior spine surgery
Refractory angina pectoris
Dorsal root ganglion (DRG) stimulation is proven and medically necessary for treating refractory complex regional pain
syndrome (CRPS I, CPRS II) in certain circumstances when performed according to U.S. Food and Drug Administration
(FDA) labeled indications, contraindications, warnings and precautions.
Dorsal root ganglion (DRG) stimulation is unproven and not medically necessary for treating all other conditions due to
insufficient evidence of efficacy.
For medical necessity clinical coverage criteria, refer to the InterQual® CP: Procedures, Spinal Cord Stimulator (SCS) Insertion.
Click here to view the InterQual® criteria.
Note: Coverage of a replacement battery/generator for a previously implanted electrical stimulator is appropriate when the
individual’s existing battery/generator is malfunctioning, cannot be repaired, and is no longer under warranty.
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Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.Documentation Requirements
Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may
require coverage for a specific service. The documentation requirements outlined below are used to assess whether the
member meets the clinical criteria for coverage but do not guarantee coverage of the service requested.
Required Clinical Information
Implanted Electrical Stimulator for Spinal Cord
Medical notes documenting the following, when applicable:
Indicate if this request is for a trial or permanent placement; if for permanent placement, include:
o Percentage of pain reduction with temporary implant
o Operative notes from the spinal cord stimulatory trial
Condition requiring procedure
o Physical examination
o Prior therapies/treatments tried, failed, or contraindicated; include the dates and reason for discontinuation
Documentation of psychological evaluation
Physician Plan of Care
For revision or removal, include documentation of:
o Details of complication
o Complete treatment plan
Applicable Codes
The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive.
Listing of a code in this guideline does not imply that the service described by the code is a covered or non-covered health
service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws
that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or
guarantee claim payment. Other Policies and Guidelines may apply.
CPT Code Description
63650 Percutaneous implantation of neurostimulator electrode array, epidural
63655 Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural
63685 Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive
coupling
63688 Revision or removal of implanted spinal neurostimulator pulse generator or receiver
CPT® is a registered trademark of the American Medical Association
HCPCS Code Description
C1767 Generator, neurostimulator (implantable), nonrechargeable
C1778 Lead, neurostimulator (implantable)
C1816 Receiver and/or transmitter, neurostimulator (implantable)
C1820 Generator, neurostimulator (implantable), with rechargeable battery and charging system
C1822 Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging
system
C1823 Generator, neurostimulator (implantable), nonrechargeable, with transvenous sensing and stimulation
leads
C1883 Adaptor/extension, pacing lead or neurostimulator lead (implantable)
C1897 Lead, neurostimulator test kit (implantable)
L8679 Implantable neurostimulator, pulse generator, any type
L8680 Implantable neurostimulator electrode, each
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Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.HCPCS Code Description
L8682 Implantable neurostimulator radiofrequency receiver
L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension
L8695 External recharging system for battery (external) for use with implantable neurostimulator, replacement
only
Clinical Evidence
Painful Diabetic Neuropathy
A 2021 Hayes report on spinal cord stimulation (SCS) for relief of neuropathic pain made the following conclusions:
• For SCS for the treatment of chronic neuropathic pain associated with complex regional pain syndrome (CRPS) or diabetic
neuropathy (DPN) that has not responded adequately to standard nonsurgical therapies there is a small body of low-quality
evidence showing some positive benefit of SCS compared with standard alternatives.
• There is uncertainty regarding the magnitude of SCS treatment benefit.
SCS is associated with a small to moderate risk of complications that may require reoperation to manage complications or
for device removal.
In 2022, D'Souza and colleagues systematically reviewed the literature for evidence on conservative, pharmacological, and
neuromodulation treatment options for painful diabetic neuropathy (PDN). The authors uncovered that intensive glycemic
control with insulin for individuals with type 1 diabetes might be related to decreased odds of distal symmetric polyneuropathy
compared to those who receive conventional insulin therapy. The first-line pharmacologic treatment for PDN includes
gabapentinoids and duloxetine. Second-line pharmacologic modalities approved by the Food and Drug Administration (FDA)
include tapentadol and an 8% capsaicin patch. The authors successfully reviewed the treatment options for PDN and noted the
high level of evidence (level 1) for dorsal column SCS for treating PDN.
Xu et al. (2022) performed a systematic review to evaluate the strength of evidence on interventional management options for
PDN and made evidence-based recommendations for clinical practice. After the completed search, ten randomized clinical
trials, eight systematic reviews/meta-analyses, and five observational studies on interventional modalities for PDN were
uncovered. Each article used pain as the primary outcome. The search revealed moderate to strong evidence supporting the
utilization of SCS for treating PDN in the lower extremities (evidence level: 1B+). Acupuncture and injection of botulinum toxin-A
showed relief in pain or muscle cramps due to PDN with minimal side effects at an evidence level of 2B+/1B+. Surgical
decompression of lower limb peripheral nerves for individuals with intractable PDN and superimposed nerve compression
yielded an evidence level of 2B±/1B+. Sympathetic blocks or neurolysis and dorsal root ganglion (DRG) stimulation were
limited to case series, resulting in an evidence level of 2C+. The authors concluded that moderate to strong evidence exists to
support the utilization of SCS for managing lower extremity pain in individuals who have failed conventional medical
management (CMM) for PDN. For individuals with PDN superimposed with nerve compression, surgical decompression of the
peripheral nerves may be considered. As adjunctive therapy for PDN, acupuncture or injection of botulinum toxin-A can be
considered. The review showed moderate to strong evidence supporting the use of SCS for managing lower extremity pain for
individuals who have failed conservative medical management for PDN.
In 2022, D'Souza and associates evaluated the current body of literature looking for evidence on neuromodulation interventions
for PDN in individuals with refractory PDN unresponsive to conventional medical management. The authors uncovered level 1
evidence supporting using 10-kHz and tonic dorsal column SCS. Other neuromodulation modalities, such as burst SCS, DRG,
and peripheral nerve stimulation, are still limited with evidence levels of II-3, III, and II-3, respectively. The authors concluded
that the literature shows how individuals undergoing 10-kHz SCS for treating PDN presented improvements in neurological
physical examination, sensory testing, and/or reflex testing in individuals experiencing 10-kHz (level of evidence: I).
Henson et al. (2021) performed a systematic review to examine the evidence and outcomes related to SCS for PDN. Fourteen
studies were reviewed. Two of the studies were randomized controlled trials with 6-month follow-up, one study provided
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Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.additional analysis of the randomized controlled trial (RCT) quality of life (QoL) data, and the remainder were prospective
observational studies. The authors reported that in the two randomized controlled trials, there was a clinically and statistically
significant improvement in lower extremity pain and QoL for individuals who received SCS. All observational studies examined
also demonstrated significant improvement in pain. The authors concluded that there was moderate-quality evidence for the
safety and efficacy of SCS for PDN. All randomized controlled trials analyzed were determined to have a significant risk of bias
due to their unblinded design. The duration of follow-up for both randomized controlled trials analyzed was only 6 months,
which may not have been adequate to assess the long-term effectiveness of this therapy.
Duarte et al. (2021) conducted a systematic review and meta-analysis on individual patient data from RCTs to assess the
effectiveness of SCS for the management of PDN. Two eligible RCTs (total of 93 patients) and 2 long-term follow-up studies of
one of the RCTs. Meta-analysis showed reductions in pain intensity for SCS compared with best medical therapy alone, on a 10-
point scale at the 6-month follow-up. More patients receiving SCS achieved at least a 50% reduction in pain intensity compared
with best medical therapy. Increases were observed for health-related QoL assessed as EuroQol 5-Dimension Questionnaire
(EQ-5D) utility score and visual analogue scale (VAS). The authors concluded that the findings demonstrated that SCS is an
effective therapeutic adjunct to best medical therapy in reducing pain intensity and improving health related QoL for individuals
with PDN. Large well-reported RCTs with long-term follow-up are required to confirm these results.
Petersen et al. (2021) conducted a prospective, multicenter, open-label SENZA-PDN randomized clinical trial to compare CMM
with 10-kHz SCS plus CMM for patients with refractory PDN. The study included 216 participants with 103 randomized to CMM
and 113 assigned to 10-kHz SCS plus CMM. The mean VAS score decreased in the 10 kHz SCS group from 7.6 cm at baseline
to 1.7 cm at six months, corresponding to 78% pain relief. The mean pain scores for the CMM group decreased from 7.0 cm at
baseline to 6.9 cm at six months. Pain worsened in 48 CMM participant (52%) and 2 SCS participant (2%) after six months. The
responder rate (≥50% pain relief) was significantly higher in the 10 kHz SCS arm (85%) than the CMM treatment arm (5%) and
the pain remission rate was 60% in the 10 kHz SCS group and 1% in CMM group. The baseline mean score on the Douleur
Neuropathique 4 (DN4) questionnaire was used to assess the neuropathic nature of pain in the study participant. The mean
DN4 decreased from 6.5 at base line to 3.5 at six-month follow-up in the 10 kHz SCS group. There was an increase from 6.4 at
baseline to 6.6 at six months in the mean DN4 score of the control group. At six months, three patients in the CMM group (3%)
and 52 in the 10 kHz SCS group (62%) demonstrated neurological improvements over baseline. Sleep disturbances due to pain
increased by 5.3% in the CMM group while decreasing 61.9% in the 10 kHz SCS group. The authors concluded that substantial
pain relief and improved health-related QoL sustained over 6 months demonstrates 10-kHz SCS can safely and effectively treat
patients with refractory PDN. Patients with PDN with inadequate pain relief despite best available medical treatments should be
considered for 10-kHz SCS.
A multi-center retrospective analysis of data extracted from a commercial real-world database of patients with painful diabetic
peripheral neuropathy (pDPN) who were trialed and permanently implanted with a 10 kHz SCS device was performed by Chen
et al. (2021). Patients (n=89) were assessed for baseline prior to 10 kHz SCS trial and at regular follow-up visits after device
implantation. Percentage of pain relief was reported at each follow-up visit. Successful response to 10 kHz SCS was defined as
at least 50% patient-reported pain relief. Patients were also asked about changes in sleep and improvement in overall function.
The average time of follow-up was 21.8 months. Most patients (78.7%) identified pain primarily in their feet or legs bilaterally. At
the last assessment, 79.5% of patients reported as having at least 50% pain relief from baseline. The average reduction in pain
during the assessment period was 60.5%. A majority reported improved sleep (78.5%) as well as improved function (76.0%).
Eighty-five percent of patients reported at least 50% pain relief was maintained over 12 months. Twenty-seven patients had
completed 24-month follow-up post-implant and 88.9% continued to report at least 50% pain relief compared to baseline. The
authors concluded that this study found 10 kHz SCS provided meaningful pain relief for a substantial proportion of patients’
refractory to current pDPN management and could provide an alternative pain management approach. Limitations of the study
include its retrospective nature and lack of randomization.
Chronic Intractable Back Pain Without Prior Spine Surgery
A 2022 ECRI report focused on how Senza compared with conventional medical management (CMM) and other spinal cord
stimulation (SCS) systems for treating chronic back, leg, and arm pain. Evidence from one systematic review with network meta-
analyses and two randomized controlled trials showed that Senza was safe and reduced pain by more than 50% for up to one
year in patients with chronic pain compared with CMM. The authors found that the studies in the SR were at high risk of bias
from three or more of the following: small sample size, retrospective design, single-center focus, and lack of randomization and
control groups. The SR included studies of patients with different pain (ECRI, 2022).
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Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.Kapural et al. (2022) conducted a multicenter, randomized controlled trial (RCT) to compare CMM with and without 10-kHz SCS
in individuals with nonsurgical refractory back pain (NSRBP). Primary and secondary endpoints included the responder rate (≥
50% pain relief), disability (Oswestry Disability Index [ODI]), global impression of change, quality of life (QoL) EuroQol 5-
Dimension Questionnaire (EQ-5D-5L) and change in daily opioid use and were analyzed at 3 and 6 months. The protocol
allowed for an optional crossover at 6 months for both arms, with observational follow-up over 12 months. One hundred and
fifty-nine individuals with NSRBP were included in the study. Seventy-six patients received CMM, and 69 patients who were
assigned to the 10-kHz SCS group received a permanent implant. At the 3-month follow-up, 80.9% of patients who received
stimulation and 1.3% of those who received CMM reported improved pain scores (≥ 50% reduction in visual analog scale
[VAS]), functional status (≥ 10-point reduction in ODI scores), and patient-perceived symptom improvement (Patient’s Global
Impression of Change [PGIC]) and QoL EQ-5D-5L scores). At 6 months in the 10-kHz SCS arm, outcomes were sustained. In the
CMM arm, 74.7% of patients met the criteria for crossover and received an implant. The crossover arm obtained a 78.2%
responder rate 6 months postimplantation. Five serious adverse events (AEs) occurred. The authors concluded that the
addition of 10-kHz SCS to CMM resulted in improvements in pain relief, function, QoL, (This trial is included in the ECRI, 2022)
report).
A systematic review was performed by Eckermann et al. (2021) to identify studies reporting outcomes for SCS in chronic back
pain patients (with or without secondary radicular leg pain) without prior surgery. The primary outcomes measured were the
magnitude of change in pain from baseline to follow-up, the proportion of subjects achieving a 50% reduction in pain, and AEs
related to the device or procedure. Outcome measures related to improvements in QoL, disability, function, and changes in
medication use were also evaluated. A total of ten studies were included (including a total of 357 patients). Final follow-up
periods across all studies ranged from 12 to 36 months. In a majority of studies, reductions in pain were observed as early as 3
months after treatment, with reductions in pain also evidenced at 6, 9, 12, 24, and 36 months postintervention. The authors
reported that the studies demonstrated favorable outcomes in terms of pain reduction and functional improvement following
SCS therapy. Improvements also occurred in quality-of-life scores; however, not all studies reported statistically significant
findings. The studies reported that SCS resulted in high patient satisfaction, reductions in opioid use, and an acceptable safety
profile, although these data were more limited. The authors concluded that SCS is a promising, safe, minimally invasive, and
reversible alternative option for managing chronic back pain in patients who have not undergone spinal surgery. The studies
were predominantly observational with relatively small sample sizes, and many studies did not have a comparison or control
group.
Baranidharan et al. (2021) performed a prospective, single center, open label trial to explore the use of SCS in patients with
associated allodynia and hyperalgesia. Twenty-one individuals with back pain and hyperalgesia or allodynia who had not had
prior spinal surgery underwent a SCS trial followed by full implantation. Patients attended follow-up visits after 6 and 12 months
of SCS. Repeated measure ANOVAs/Friedman tests explored change after 6 and 12 months of 10 kHz SCS. Independent
sample t-tests/Mann-Whitney U tests examined differences in response after 12 months. The authors reported that compared to
baseline, 12 months of 10 kHz SCS was associated with improvements in back and leg pain, health-related QoL, pain-related
disability and medication consumption. After 12 months of treatment, 52% of patients had ≥ 50% improvement in back pain,
44% achieved remission for back pain, 40% reported ODI scores between 0 and 40 and 60% experienced a reduction of at
least 10 ODI points. Limitations of this study included a small sample size, short follow-up period, and no control group (This
trial is included in the Eckermann, (2021) study).
A prospective, multicenter, RCT (SENZA-RCT) was conducted by Amirdelfan et al. (2018). Patients with both chronic intractable
back and leg pain were enrolled and randomized (1:1) into 10 kHz SCS or traditional SCS treatment groups. A total of 171
subjects received a permanent SCS device implant. QoL and functionality measures were collected up to 12 months. At 12
months, in the 10 kHz SCS group, 69.6% of the individuals had an improved ODI score. Individuals reported better
improvement in the Global Assessment of Functioning, Clinician Global Impression of Change, Pittsburgh Sleep Quality Index,
and short-form McGill Pain Questionnaire, compared to traditional SCS participants. The authors concluded that in addition to
superior pain relief, 10 kHz SCS provided long-term improvements in QoL and functionality for patients with chronic low-back
and leg pain. The study was limited by the heterogeneity of pain diagnoses and lack of masking to the assigned treatment
group (This trial is included in the ECRI 2022 report).
Refractory Angina Pectoris
A single center prospective observational study was performed by Vervaat et al. (2020) to show the effects of spinal cord
stimulation (SCS) on the severity of angina complaints and quality of life (QoL). Eighty-seven patients with refractory angina
pectoris (RAP) received SCS. Ninety-two percent had angina pectoris CCS class III or IV. Ischemia was proven by MIBI-SPECT
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to implantation, and 1 year post-implantation. After 1 year of follow-up there was a decrease in the frequency of angina pectoris
attacks from more than 4 times a day to 1-2 times a week (p < 0.001). The SAQ showed improvement in four of the five
dimensions: physical limitation (p < 0.001), angina frequency (p < 0.001), angina stability (p < 0.001) and QoL (p < 0.001). The
improvement in satisfaction with treatment was not statistically significant (p = 0.55). The RAND-36 showed improvement in all
nine dimensions: physical functioning (p = 0.001), role/physical (p < 0.001), social functioning (p = 0.03), role/emotional (p <
0.05), bodily pain (p < 0.001), general health (p < 0.001), vitality (p < 0.001), mental health (p = 0.02) and health change (p <
0.001). Secondary findings of this study were a reduction in the use of short-acting NTG use from 1–3 times a day to less than
once a week, low cardiovascular mortality (1.1%) and low all-cause mortality (3.4%). The authors concluded that the study
showed a significant improvement in QoL and reduction of angina pectoris severity after 1 year of follow-up in patients treated
with SCS for RAP. This was a nonrandomized study design without a control group.
Pan et al. (2017)) conducted a systematic review and meta-analysis to evaluate the efficacy and safety of conventional SCS in
the treatment of rRAP. Five meta-analyses were performed examining the changes in Canadian Cardiovascular Society classes,
exercise time, Visual Analog Scale (VAS) scores of pain, Seattle Angina Questionnaire, and nitroglycerin use in RAP patients
after SCS therapy. Twelve randomized controlled trials involving 476 RAP patients were included. The results identified
reduction in the angina frequency and nitroglycerin consumption in the SCS group. Compared with the control group, SCS
showed benefit on increasing exercise time and treatment satisfaction with decreased VAS scores of pain and disease
perception. The result did not reach the significance level in terms of physical limitation (P=0.39) or angina stability (P=0.50).
The authors concluded that SCS relieves the symptoms of angina pectoris without increasing the nitroglycerin consumption to
some extent. Future larger outcome studies for finding the appropriate intensity of stimulation are needed.
A systematic review and meta-analysis were conducted by Imran et al. (2017) to examine whether SCS is associated with
changes in exercise capacity and angina severity. Fourteen studies with 518 participants were included. SCS implant duration
ranged from 3 weeks to 5 years (median: 6 months). The results found that SCS was associated with a higher exercise duration
and lower angina severity, 1.55 less daily angina episodes, 1.54 less daily nitrates consumed, and a 22 points higher SF-36
angina frequency score on follow-up. The authors concluded that SCS, as an adjunct therapy to medical management, may be
associated with a longer exercise duration and lower angina frequency and nitrate consumption in patients with chronic RAP
who are not candidates for percutaneous intervention or revascularization. Further studies, including randomized trials with a
long-term follow-up, are needed to validate these findings.
Tsigaridas et al. (2015) conducted a systematic review of randomized controlled trials (RCTs) to investigate the effectiveness of
SCS as a treatment for refractory angina. Nine RCTs were categorized into two groups: RCTs comparing SCS either with
optimal medical treatment or inactive mode or low stimulation SCS; and those comparing SCS with alternative therapeutic
interventions. Follow-up was 1-6 months in most studies, showing no major complications. Two studies reported a neutral effect
regarding mortality. The most recent, multi-center RCT reported no significant difference compared to the control group. The
authors concluded that RCTs investigating the efficacy of SCS were small and they demonstrated a small effect in angina
improvement. Larger, well-designed, multicenter RCTs are needed with longer follow-up.
Dorsal Root Ganglion (DRG) Stimulation
In 2022, Moman and colleagues led a systematic review and pooled analysis to decide the overall incidence of DRGs
infections, occurrence at each stage, infection characteristics, and outcomes. Out of the ten studies that met inclusion criteria,
eight reported on individuals with trial data, resulting in 291 individuals; ten articles reported on those with implant data,
resulting in 250 individuals; and lastly, articles that reported on revisions resulted in twenty-six individuals. The pooled incidence
of trial infections was 1.03% (95% CI 0.35-2.99%), implant infections was 4.80% (95% CI 2.77-8.20%), revision infections results
were 3.85% (95% CI 0.20-21.59%), and overall infections results were 2.82% (95% CI 1.62-4.54%). There was a statistically
significant difference in infection rates between the trial, implant, and revision stages, X2 (2, N = 567) = 8.9839, p = 0.01. The
results prove the DRG's trials appear to be low risk for infection however, the risk is increased when the DRG is implanted. The
authors conclude there is a need for further studies on infectious complications, risks, and best prophylaxis.
Hagedorn et al. (2022) conducted a systematic review and meta-analysis to find the number of individuals satisfied with using
spinal cord stimulation (SCS) and DRG-S for treating chronic intractable pain. The authors uncovered 242 citations, including
nine randomized controlled trials (RCTs), and 23 observational studies, resulting in the utilization of 25 studies comprising
1,355 individuals. A quantitative analysis was conducted, and the pooled portion of individuals who reported satisfaction from
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analysis revealed no differences in satisfaction when articles were stratified according to study design or follow-up period. The
author’s concluded individuals are highly satisfied with SCS and DRG-S when the treatment modalities are utilized for chronic
intractable pain. Limitations include the scarcity of unbiased and/or non-industry-funded prospective studies, and future efforts
to expand this area of SCS and DRG-S literature are necessary.
Stelter et al. (2021) conducted a systematic review of clinical studies demonstrating the use of DRGS for non-CRPS-related
chronic pain syndromes. A total of twenty-eight studies comprising 354 total patients were included in the review. Of the
chronic pain syndromes presented, axial low back pain, chronic pelvic and groin pain, and other peripheral neuropathies, a
majority demonstrated >50% mean pain reduction at the time of last follow-up. Physical function, quality of life (QOL), and lesser
pain medication usage also were reported to be significantly improved. The authors concluded that evidence from lower level
studies did show success with the use of DRGS for various non-CRPS chronic pain syndromes in reducing pain along with
increasing function and QOL from one week to three years. DRGS continues to lack supportive evidence from well designed,
high level studies and recommendations from consensus committee experts.
A systematic review was conducted by Nagpal et al. (2021) to evaluate the effectiveness of DRG neurostimulation for the
treatment of refractory, focal pain in the pelvis and lower extremities. The primary outcome was ≥50% pain relief. Secondary
outcomes were physical function, mood, QoL, opioid usage, and complications. One randomized controlled trial, four
prospective cohort studies, and eight case series were included in the review. The RCT reported ≥50% pain relief in 74% of
patients with DRG neurostimulation vs. 51% of patients who experienced at least 50% relief with SCS at 3 months. Cohort data
success rates ranged from 43% to 83% at ≤6 months and 27% to 100% at >6 months. Significant improvements were also
reported in the secondary outcomes assessed, including mood, QoL, opioid usage, and health care utilization, though a lack of
available quantitative data limited further statistical analysis. The only RCT reported a higher rate of adverse events (AEs) than
that seen with traditional neurostimulation. The authors concluded that low-quality evidence supported DRG neurostimulation
as a more effective treatment than traditional neurostimulation for pain and dysfunction associated with complex regional pain
syndrome (CRPS) or causalgia. Very low-quality evidence supported DRG neurostimulation for the treatment of chronic pelvic
pain, chronic neuropathic groin pain, phantom limb pain, chronic neuropathic pain of the trunk and/or limbs, and diabetic
neuropathy (DPN).
A 2021 Hayes health technology assessment was conducted to evaluate the safety and effectiveness of DRG stimulation for the
treatment of CRPS in adults with CRPS in the lower extremities. The literature search identified 5 studies that met the inclusion
criteria; one RCT compared DRG stimulation with spinal cord stimulation (SCS) after 12 months of treatment, three pretest-
posttest studies assessed outcomes in terms of change from baseline (CFBL) following 3 to 12 months of treatment with DRG
stimulation., and a retrospective chart review assessed outcomes during the post implantation period in patients undergoing
DRG stimulation. The authors concluded that a limited evidence base suggests that DRG stimulation may be associated with
treatment success and improved outcomes for pain, QOL, and mood compared with baseline levels or SCS treatment. Two
studies suggested that treatment benefits associated with DRG stimulation were observed for patients with CRPS type I and
type II. Well-designed comparative studies are needed to evaluate comparative benefits versus harms. The effectiveness and
safety of DRG stimulation for the treatment of neuropathic pain associated with other chronic pain etiologies (e.g., cancer;
postherpetic neuralgia; DPN; central neuropathic pain due to multiple sclerosis, stroke, ischemia, or amputation) are unknown
(Hayes, 2021a).
A 2021 ECRI clinical evidence assessment focused on Proclaim DRG Neurostimulation System’s safety and effectiveness for
treating CRPS. The report included one RCT, 1 within-subjects comparative study, and 5 case series and found low-strength,
but conclusive evidence that DRG with Proclaim relieves pain as much or more than SCS at up to 3-month follow up for in
patients with CRPS. Larger, multicenter studies reporting on 1- to 5-year outcomes are needed to confirm Proclaim’s
effectiveness for treating CRPS. The RCT was at risk of bias from lack of blinding. The other included studies were at high risk
of bias from lack of independent controls and small sample sizes.
Horan et al. (2021) performed an observational, multicenter cohort study of all patients in Denmark implanted with FDA-
approved DRG stimulation systems to treat chronic, neuropathic pain between 2014 and 2018. Follow-up period was one to
three years. Forty-three patients underwent trial DRG stimulation; 33 were subsequently fully implanted. Pain location: 58%
lower extremity; 21% upper extremity; 21% thoracic/abdominal. At the end of the observation period, 58% of fully implanted
patients were still implanted; 42% had fully functional systems. In these patients, average Numerical Rating Scale (NRS)-score
of pain was reduced from 6.8 to 3.5 and worst NRS-score was reduced from 8.6 to 6.0 at 12 months follow-up. Pain
Catastrophizing Score was reduced from 32 to 15. Thirteen patients experienced complications related to defect leads (39% of
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suffered permanent nerve damage during attempts to replace broken leads. The authors concluded that this study suggested a
significant, clinically relevant effect of DRG stimulation on neuropathic pain, but also demonstrates substantial problems with
maintenance and revision of currently available systems. This is an uncontrolled study with a small sample size. Additional
multi-center, prospective, randomized trials with longer follow-up are still needed to elucidate DRG’s role in the treatment
of peripheral nerve injury (PNI).
Kretzschmar et al. (2021) conducted a retrospective chart review of patients who underwent DRG stimulation for the treatment
of chronic neuropathic pain after PNI at a single German center between January 2013 and December 2015. Twenty-seven
patients were trialed with a DRG neurostimulation system for PNI; trial success (defined as ≥50% pain relief) was 85%, and 23
patients received a permanent stimulator. Thirty-six month outcome data was only available for 21 patients. Pain, QoL, mental
and physical function, and opioid usage were assessed at baseline and at 3-, 6-, 12-, 18-, 24-, and 36 months post-permanent
implant. Compared to baseline, a significant pain relief was noted at 3 (58%), 12 (66%), 18 (69%), 24 (71%), and 36 months
(73%) in 21 patients respectively. Mental and physical function showed immediate and sustained improvements. Participants
reported improvements in QoL. Opioid dosage reduced at 3 (30%), 12 (93%), 18 (98%), 24 (99%), and 36 months (99%), and 20
of 21 patients were completely opioid-free after 36 months. The authors concluded that DRG neuromodulation appeared to be
a safe, effective, and durable option for treating neuropathic pain caused by PNI. The study is limited by its retrospective
observations and small sample size.
Kallewaard et al. (2020) performed a prospective, single-arm post-market pilot study to determine the effect of DRG stimulation
for a group of patients with discogenic LBP with no history of previous back surgeries. Twenty subjects with confirmed
discogenic LBP and no prior history of back surgery underwent trials of DRG stimulation and, if successful with at least 50%
pain reduction, were permanently implanted. Subjects rated their pain, disability, QoL, and mood at baseline, and 14 subjects
were followed through 12 months of treatment. Treatment with DRG stimulation reduced LBP ratings (68.3% reduction), from
mean 7.20 at baseline to 2.29 after 12 months. Oswestry ratings of disability decreased from 42.09 at baseline to 21.54 after six
months of treatment and to 20.1 after 12 months. The average QoL EuroQol 5-Dimension Questionnaire (EQ-5D) index score at
baseline was 0.61 and 0.84 after 12 months. The authors concluded that DRG stimulation treatment for discogenic LBP
improved the level of pain, function, and QoL. This study is limited by a small study population.
Mekhail et al. (2020) performed a retrospective analysis of therapy outcomes on 61 individuals in the ACCURATE study who
received a permanent DRG neurostimulator. Outcomes of individuals who were paresthesia-free were compared to those who
experienced paresthesia-present therapy at 1, 3, 6, 9, and 12-month follow-up. The percentage of individuals with paresthesia-
free pain relief increased from 16.4% at 1-month to 38.3% at 12-months. Paresthesia-free subjects generally had similar or
better outcomes for pain severity, pain interference, QoL, and mood state as subjects with paresthesia-present stimulation.
Factors that increased the odds of an individual feeling paresthesia were higher stimulation amplitudes and frequencies,
number of implanted leads, and younger age. The authors concluded that some DRG subjects achieved effective paresthesia-
free analgesia in the ACCURATE trial, and this supported the observation that paresthesia is not synonymous with pain relief or
required for optimal analgesia with DRG stimulation. (This study is included in the Hayes 2021a report).
Neuromodulation Appropriateness Consensus Committee (NACC), an international, interdisciplinary work group conducted a
systematic literature review of DRG stimulation for pain. Inclusion criteria were prospective trials (randomized controlled trials
and observational studies). Studies were graded using the modified Interventional Pain Management Techniques-Quality
Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US
Preventative Services Task Force level-of-evidence criteria. The group concluded that DRG stimulation has Level II evidence
(moderate) based upon one high-quality pivotal RCT and two lower-quality studies. Moderate-level evidence supports DRG
stimulation for treating chronic focal neuropathic pain and CRPS (Deer, 2020).
Huygen et al. (2020) conducted a meta-analysis to identify differences in outcome between chronic pain etiologic subgroups
and/or pain location. One prospective, randomized comparative trial and six prospective, single-arm, observational studies
were included. Pain scores and patient-reported outcome (PRO) measures were weighted by study sample sizes and pooled.
The study included 217 patients with a permanent implant at 12-month follow-up. The analysis showed an overall weighted
mean pain score of 3.4, with 63% of patients reporting ≥50% pain relief. Effectiveness sub-analyses in CRPS-I, causalgia, and
back pain resulted in a mean reduction in pain intensity of 4.9, 4.6, and 3.9 points, respectively. The analysis showed a pain
score for primary affected region ranging from 1.7 (groin) to 3.0 (buttocks) and responder rates of 80% for foot and groin, 75%
for leg, and 70% for back. The most commonly reported complications were pain at the IPG pocket site, lead fracture, lead
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for patients that have failed to receive pain relief and QoL improvements from other interventions. Data of most patients in the
analysis came from industry sponsored studies. Further research with randomized controlled trials is needed to validate these
findings.
A systematic review about patient selection, efficacy, and safety of neuromodulation with electrical field stimulation (EFS) DRG
in various painful conditions was conducted by Vuka et al. (2019). Twenty-nine studies were included, one RCT, case series,
and case reports. Included studies analyzed the following painful conditions: CRPS, LBP, groin pain, pelvic girdle pain,
peripheral neuropathy, peripheral DPN, phantom limb pain, chronic intractable pain in the coccyx, chronic testicular pain,
anterior cutaneous nerve entrapment syndrome (ACNES), loin pain hematuria syndrome (LPHS). CRPS was the most common
indication treated. The evidence is based on studies with small number of participants (median: 6, range 1-152).
Neuromodulation with EFS of DRG was mostly performed in participants who have failed other treatment modalities. Most of
the authors of the included studies reported positive, but inconclusive, evidence regarding efficacy of neuromodulation with
EFS of DRG. Meta-analysis was not possible since only one RCT was included. The most common SAE related to stimulation
was overstimulation. The authors concluded that the evidence suggested that neuromodulation with EFS of DRG may help
highly selected participants with various pain syndromes, who have failed to achieve adequate pain relief with other
pharmacological and nonpharmacological interventions. Study limitations included poor quality of studies, very small number of
participants included, highly selected patient population, and conflict of interest of sponsors and authors.
Deer et al (2017) conducted a prospective, multicenter, randomized comparative effectiveness trial (known as the ACCURATE
trial) in 152 subjects diagnosed with CRPS or causalgia in the lower extremities. Subjects received neurostimulation of the DRG
or dorsal column. The primary end point was a composite of safety and efficacy at 3 months, and subjects were assessed
through 12 months for long-term outcomes and AEs. The predefined primary composite end point of treatment success was
met for subjects with a permanent implant who reported 50% or greater decrease in visual analog scale (VAS) score from pre-
implant baseline and who did not report any stimulation-related neurological deficits. No subjects reported stimulation-related
neurological deficits. The percentage of subjects receiving ≥ 50% pain relief and treatment success was greater in the DRG arm
(81.2%) than in the SCS arm (55.7%) at 3 months. Device-related and serious AEs were not different between the 2 groups.
DRG stimulation also demonstrated greater improvements in QOL and psychological disposition. Finally, subjects using DRG
stimulation reported less postural variation in paresthesia and reduced extraneous stimulation in non-painful areas, indicating
DRG stimulation provided more targeted therapy to painful parts of the lower extremities. The researchers concluded that DRG
stimulation provided a higher rate of treatment success with less postural variation in paresthesia intensity compared to SCS.
Additional prospective randomized trials with longer follow-up are still needed to clarify the safety and efficacy of DRG in
patients with CRPS or causalgia. (This study is included in the Hayes 2021a report).
Schu et al. (2015) conducted a retrospective review of data from patients with groin pain of various etiologies treated using
neuromodulation of the DRG. Twenty-nine patients with neuropathic groin pain were reviewed. Pain scores were captured on a
VAS at baseline and at regular follow-up visits. Twenty-five patients (86.2%) received fully implantable neurostimulators, and the
average follow-up period was 27.8 ± 4.3 weeks. The average pain reduction was 71.4 ± 5.6%, and 82.6% (19/23) of patients
experienced a > 50% reduction in their pain at the latest follow-up. Individual cases showed improvement with a variety of
etiologies and pain distributions; a sub analysis of post-herniorrhaphy cohort also showed significant improvement. The authors
concluded that early findings suggest that neuromodulation of the DRG may be an effective treatment for chronic neuropathic
pain conditions in the groin region. This technique offers a useful alternative for pain conditions that do not always respond
optimally to traditional SCS therapy. Neuromodulation of the DRG provided excellent cross-dermatomal paresthesia coverage,
even in cases with patients with discrete pain areas. The therapy can be specific, sustained, and independent of body position.
Study limitations include non-randomization and small sample size.
Clinical Practice Guidelines
American College of Cardiology Foundation/American Heart Association Task Force (ACCF/AHA)
In 2013, Anderson et al. reported on the ACCF/AHA guidelines for managing individuals with unstable angina/non-ST elevated
myocardial infarctions. Regarding spinal cord stimulation (SCS), the guidelines read: “Other less extensively studied therapies
for relieving ischemia, such as SCS and prolonged external counterpulsation, are under evaluation. Most experience has been
gathered with SCS in ‘intractable angina’ in which anginal relief has been described. They have not been applied in the acute
setting for UA/NSTEMI.”
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Guidelines and the Heart Rhythm Society (AHA/ACC/HRS)
In 2018, Al-Khatib et al. reported that the AHA/ACC/HRS found limited data on the role of vagal nerve stimulators and SCS in
the prevention of VA/SCD; therefore, no formal recommendation has been supported.
Department of Veterans Affairs Department of Defense (VA/DoD)
A 2022 VA/DoD Clinical Practice Guideline for the diagnosis and treatment of low back pain recommended against SCS for
patients with low back pain.
National Institute for Health and Care Excellence (NICE)
In 2019, NICE supplied recommendations for the Senza SCS system for delivering HF10 therapy to treat chronic neuropathic
pain. The recommendations are as follows:
The case for adopting Senza SCS for delivering HF10 therapy as a treatment possibility for chronic neuropathic back or leg
pain after the evidence supports failed back surgery. HF10 therapy using Senza SCS is at least as effective as
low-frequency SCS in reducing pain and functional disability and avoids the experience of tingling sensations (paresthesia).
Senza SCS for delivering HF10 therapy should be considered for individuals:
o With residual chronic neuropathic back or leg pain (at least 50 mm on a 0 mm to 100 mm visual analog scale [VAS]) at
least six months after back surgery despite conventional medical management (CMM) and
o Who has had a successful stimulation trial as part of a more comprehensive assessment by a multidisciplinary team.
Individuals with other causes of neuropathic pain were included in the evaluation and may be considered for HF10 therapy
using Senza SCS but any added benefits compared with low-frequency SCS are less specific. Cost modeling shows that
over 15 years, HF10 therapy using Senza SCS has similar costs to low-frequency SCS using either a rechargeable or non-
rechargeable device.
Clinicians implanting SCS devices, including Senza, should send prompt and complete data to the UK Neuromodulation
Registry.
When assessing the severity of pain and the stimulation trial, the multidisciplinary team should be aware of the need to
ensure equal access to treatment with SCS. Tests to assess pain and response to SCS should consider a person's
disabilities (such as physical or sensory disabilities) or linguistic or other communication difficulties and may need to be
adapted.
According to NICE, 2008 the guidance on SCS reads as follows:
SCS is recommended as a treatment possibility for adults with chronic pain of neuropathic origin who:
o Continue to experience chronic pain (measuring at least 50 mm on a 0–100 mm VAS) for at least six months despite
proper conventional medical management, and
o Who have had a successful stimulation trial as part of the assessment specified in the recommendation.
SCS is not recommended as a treatment possibility for adults with chronic pain of ischemic origin except in the context of
research as part of a clinical trial. Such research should be designed to generate robust evidence about the benefits of
SCS (including pain relief, functional outcomes, and quality of life) compared with standard care.
SCS should be provided only after an assessment by a multidisciplinary team experienced in chronic pain assessment and
management of people with SCS devices, including experience in the provision of ongoing monitoring and support of the
person assessed.
When assessing the severity of pain and the stimulation trial, the multidisciplinary team should be aware of the need to
ensure equal access to treatment with SCS. Tests to assess pain and response to SCS should consider a person's
disabilities (such as physical or sensory disabilities) or linguistic or other communication difficulties and may need to be
adapted.
If different SCS systems are equally suitable for a person, the least costly should be used. Assessment of cost should
consider acquisition costs, the predicted longevity of the system, the stimulation requirements of the person with chronic
pain, and the support package offered.
People who are currently using SCS for treating chronic pain of ischemic origin should have the choice to continue
treatment until they and their clinicians consider it right to stop.
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The 2020 NASS Evidence Based Clinical Guideline for the diagnosis and treatment of low back pain systematic review of the
literature yielded no studies to adequately address electrical stimulation for low back pain.
U.S. Food and Drug Administration (FDA)
This section is to be used for informational purposes only. FDA approval alone is not a basis for coverage.
Implantable spinal cord stimulation systems for pain relief are regulated by the FDA as Class III devices and are approved
through the Premarket Approval (PMA) process. See the following website for more information (use product code LGW):
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. (Accessed October 17, 2022)
There are several devices used for DRG stimulation. See the following website for more information and search by product
code PMP: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. (Accessed October 17, 2022)
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